REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer… — Class II medical device recall Z-0542-2026
Ongoing recall by Cellavision AB, reported 2025-11-26, distributed nationwide. Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting
| Recall number | Z-0542-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cellavision AB, Lund, Sweden |
| Recall initiated | 2025-10-08 |
| Classified | 2025-11-18 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 688 units |
| Serial numbers | 60001-63219, 63220-70093, CN60001-CN63219, CN63220-CN70093 |
| Model numbers | BS737162, CC286297 |
Product
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Reason for recall
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0542-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.